U.S. patent number 6,641,573 [Application Number 09/611,042] was granted by the patent office on 2003-11-04 for device and method of guide wire balloon inflation and deflation to prevent cerebral embolization during carotid stenting.
This patent grant is currently assigned to Arteria Medical Science, Inc.. Invention is credited to Juan Carlos Parodi.
United States Patent |
6,641,573 |
Parodi |
November 4, 2003 |
Device and method of guide wire balloon inflation and deflation to
prevent cerebral embolization during carotid stenting
Abstract
A device and method for inflating and deflating a balloon, used
to protect the cerebrum against emboli, during carotid stenting, is
provided wherein the device comprises a balloon carried on a guide
wire and wherein inflation can be accomplished without the need of
a port on the guide wire, so that coaxial systems may be applied
over the guide wire. The device comprises a guide wire having an
interior lumen and a balloon that communicates with the lumen. A
core segment is inserted into the open end of the guide wire, and
serves as a piston to inflate the balloon after saline is
introduced into the lumen. A locking mechanism is provided to
retain the core segment in position during the procedure. Coaxial
systems, such as balloon catheters and stent delivery systems, can
be applied over the guide wire without deflating the guide wire
balloon.
Inventors: |
Parodi; Juan Carlos (Buenos
Aires, AR) |
Assignee: |
Arteria Medical Science, Inc.
(San Francisco, CA)
|
Family
ID: |
27064141 |
Appl.
No.: |
09/611,042 |
Filed: |
July 6, 2000 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
533318 |
Mar 22, 2000 |
|
|
|
|
Current U.S.
Class: |
604/510;
604/164.13; 604/192; 604/264; 604/96.01 |
Current CPC
Class: |
A61M
25/09 (20130101); A61M 25/10 (20130101); A61M
2025/09008 (20130101); A61M 2025/09125 (20130101); A61M
2025/09183 (20130101); A61M 2025/1068 (20130101); A61M
2210/0693 (20130101) |
Current International
Class: |
A61M
25/10 (20060101); A61M 029/00 () |
Field of
Search: |
;604/97.01,96.01,99.01,164.01,164.02,164.13,165.01,523,533,264,500,506-510
;606/191,192,194 ;623/1.11 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Le; Long V.
Assistant Examiner: Lam; Ann Y
Attorney, Agent or Firm: Luce, Forward, Hamilton &
Scripps Pisano; Nicola A.
Parent Case Text
REFERENCE TO RELATED APPLICATIONS
The present application is a continuation-in-part of U.S. patent
application Ser. No. 09/533,318 filed Mar. 22, 2000, now abandoned
which claims benefit from the filing date of provisional U.S.
patent application Ser. No. 60/126,556 filed Mar. 26, 1999, and
further claims benefit from the filing date of provisional U.S.
patent application Ser. No. 60/126,208 filed Mar. 25, 1999.
Claims
What is claimed is:
1. A device for inflating and deflating a guide wire balloon, the
device comprising: a guide wire having a lumen, an orifice
extending from the exterior of the guide wire to the lumen, and two
ends, the two ends comprising a closed end and an open end, wherein
the lumen provides fluid communication between the orifice and the
open end; an inflatable guide wire balloon coupled to the guide
wire in communication with the orifice; a core segment disposed
within the lumen of the guide wire, the core segment configured for
removal from the lumen of the guide wire, thereby establishing a
vacuum in the lumen that facilitates inflation of the guide wire
balloon; a plurality of orifices extending from the exterior of the
guide wire to the lumen, wherein the open end of the guide wire is
dimensioned to permit a coaxial angioplasty balloon catheter or
stent delivery catheter to be exchanged over the guide wire and at
least partially over said core segment from the open end to a
position just proximal of the balloon without deflating the
balloon.
2. The device of claim 1, further comprising a solution in
communication with the open end of the guide wire, the core segment
removed from and then advanced into the lumen of the guide wire to
inflate the guide wire balloon with the solution.
3. The device of claim 2, further comprising a plurality of
orifices extending from the exterior of the guide wire to the
lumen.
4. The device of claim 1, further comprising a locking mechanism
configured to lock the core segment in a fixed position within the
lumen of the guide wire to maintain the guide wire balloon in an
inflated configuration.
5. The device of claim 2, further comprising a locking mechanism
configured to lock the core segment in a fixed position within the
lumen of the guide wire to maintain the guide wire balloon in an
inflated configuration.
6. The device of claim 1, further comprising a locking mechanism
configured to lock the core segment in a fixed position within the
lumen of the guide wire to maintain the guide wire balloon in an
inflated configuration.
7. The device of claim 4, wherein the locking mechanism is disposed
within the lumen of the guide wire.
8. The device of claim 5, wherein the locking mechanism is disposed
within the lumen of the guide wire.
9. The device of claim 1, further comprising a coaxial angioplasty
balloon catheter or stent delivery catheter configured for exchange
over the guide wire while the guide wire balloon is in an inflated
configuration.
10. The device of claim 2, further comprising a coaxial angioplasty
balloon catheter or stent delivery catheter configured for exchange
over the guide wire while the guide wire balloon is in an inflated
configuration.
11. The device of claim 1, further comprising a coaxial angioplasty
balloon catheter or stent delivery catheter configured for exchange
over the guide wire while the guide wire balloon is in an inflated
configuration.
12. The device of claim 3, further comprising a coaxial angioplasty
balloon catheter or stent delivery catheter configured for exchange
over the guide wire while the guide wire balloon is in an inflated
configuration.
13. The device of claim 4, further comprising a coaxial angioplasty
balloon catheters or stent delivery catheter configured for
exchange over the guide wire while the guide wire balloon is in an
inflated configuration.
14. The device of claim 4, wherein the locking mechanism further
comprises: a groove disposed on the guide wire, the groove
extending longitudinally along the guide wire from the open end; a
side housing space disposed on the guide wire perpendicular to the
groove; and a knob disposed on the core segment, the knob
configured to engage the housing space and lock the core segment to
the guide wire.
15. The device of claim 5, wherein the locking mechanism further
comprises: a groove disposed on the guide wire, the groove
extending longitudinally along the guide wire from the open end; a
side housing space disposed on the guide wire perpendicular to the
groove; and a knob disposed on the core segment, the knob
configured to engage the housing space and lock the core segment to
the guide wire.
16. The device of claim 6, wherein the locking mechanism further
comprises: a groove disposed on the guide wire, the groove
extending longitudinally along the guide wire from the open end; a
side housing space disposed on the guide wire perpendicular to the
groove; and a knob disposed on the core segment, the knob
configured to engage the housing space and lock the core segment to
the guide wire.
17. The device of claim 4, further comprising a plurality of side
housing spaces disposed on the guide wire perpendicular to the
groove.
18. The device of claim 4, further comprising a further comprising
a sealing mechanism configured to prevent fluid leakage around the
core segment when the core segment is disposed within the guide
wire.
19. The device of claim 5, further comprising a sealing mechanism
configured to prevent fluid leakage around the core segment when
the core segment is disposed within the guide wire.
20. The device of claim 6, further comprising a sealing mechanism
to prevent fluid leakage around the core segment when the core
segment is disposed within the guide wire.
21. The device of claim 3, further comprising a sealing mechanism
configured to prevent fluid leakage around the core segment when
the core segment is disposed within the guide wire.
22. The device of claim 21, wherein the sealing mechanism comprises
a plurality of rings coupled to the core segment.
23. The device of claim 22, wherein the sealing mechanism further
comprises a layer of silicone coupled to a distal end portion of
the core segment to prevent leakage of fluid around the core
segment.
24. A method for inflating and deflating a guide wire balloon,
comprising the steps of: providing apparatus comprising a guide
wire having a lumen, an open end, and a closed end, an inflatable
guide wire balloon coupled to the guide wire, and a core segment
disposed within the lumen; inserting the closed end of the guide
wire into a patient's vessel; situating the guide wire balloon at a
position of intended use; inserting the open end of the guide wire
into a solution; removing, at least partially, the core segment
from the lumen of the guide wire to cause the solution to move into
the lumen of the guide wire to facilitate inflation of the guide
wire balloon; advancing the core segment toward the guide wire
balloon until the guide wire balloon is inflated; and exchanging a
coaxial angioplasty balloon catheter or stent delivery catheter
over the guide wire from the open end to a position just proximal
of the balloon without deflating the balloon.
25. The method of claim 24, further comprising the step of: locking
the core segment within the guide wire to maintain inflation of the
guide wire balloon.
26. The method of claim 25, further comprising the step of:
unlocking the core segment within the guide wire; and withdrawing
the core segment from the lumen of the guide wire to allow
deflation of the guide wire balloon.
27. The method of claim 24, further comprising the step of:
advancing a coaxial angioplasty balloon catheter or stent delivery
catheter over the guide wire without deflating the guide wire
balloon.
Description
FIELD OF THE INVENTION
This invention relates to a device and method for inflating and
deflating a balloon used to protect the cerebrum against emboli
during carotid stenting, where the balloon is carried on a guide
wire and where the inflation can be accomplished without the need
of a port on the guide wire. Coaxial systems may be applied over
the guide wire, because the outside of the guide wire is of a
smooth surface with no ports.
The device comprises a guide wire, having a lumen inside the guide
wire. The guide wire has one end occluded and the other end open,
and has a balloon at the occluded end. The guide wire has two or
three orifices, each extending from the exterior of the guide wire
to reach the lumen of the guide wire. Thus, the lumen of the guide
wire is connected to the inside of the balloon through these
orifices. The area of the guide wire with the orifices is covered
by a silicon or polyurethane balloon. A core segment is inserted
into the open end of the guide wire to the closed end of the guide
wire before the orifices on the guide wire are covered by a
balloon. The core segment may be removed from the guide wire when
the open end of the guide wire is inside a basin full of normal
saline mixed with non-ionic contrast media solution. When the core
segment is removed, it creates a vacuum inside the lumen of the
guide wire which is filled immediately with the solution. Then, the
core segment is gently advanced until the balloon is fully
distended. Through a locking mechanism, the core segment is kept in
position during the time needed for the procedure. Coaxial systems,
such as balloon catheter and stent delivery systems, may be applied
over the guide wire. After the procedure which may generate emboli
is completed, the core segment is unlocked and retrieved and the
balloon is thereby deflated.
BACKGROUND OF THE INVENTION
Although traditionally conventional open surgery has been used in
treatments of vascular diseases, such as stenosis of the carotid
artery, nowadays endovascular treatments are gaining acceptance.
Endovascular treatments are carried out in the lumen of the
vascular duct and have the advantage of being less aggressive than
the conventional open surgery posing less risk to the patient
because it can be performed under limited local anesthesia and
without surgery.
Where there is stenosis of an artery, such as the common carotid
artery, the internal carotid artery or the external carotid artery,
the vascular wall of the artery is affected by a pathologic
narrowing that prevents the blood stream from flowing normally. A
common treatment consists of endovascular angioplasty, where an
angioplasty balloon is inserted into the lumen of the blood vessel
and the angioplasty balloon is expanded in order to expand the area
having the stenosis. If necessary, a stent is placed to cover the
afflicted area.
Balloon angioplasty and stenting are a rapidly growing field in
vascular intervention. The main and dreadful complication of
carotid balloon angioplasty and stenting is cerebral embolization.
Several studies have shown that the incidence of embolization is
high during these procedures.
The problem in this treatment is that emboli can be formed during
the course of the procedure which can rapidly reach the brain and
cause injury and death. Emboli are especially prone to be formed
when the angioplasty balloon is expanded or while the stent is
placed and expanded.
Investigators, such as Jack Theron, used a balloon to prevent
particles generated in the affected area from reaching the brain.
U.S. Pat. No. 5,833,650 of inventor Imran, entitled Catheter
Apparatus and Method for Treating Occluding Vessells, issued Nov.
10, 1998. The Imran patent described a system to achieve cerebral
protection using a guide wire and inflated balloons, which allowed
the advancement over the guide wire of a coaxial system of balloon
angioplasty catheters and stent delivery systems. The use of
occlusion balloons to protect the brain during carotid balloon
angioplasty and stenting (CBAS) was presented publicly by Theron in
Milwaukee in 1994.
Difficulty exists in keeping the occlusion balloon inflated and
undisturbed when changing the coaxial systems. The ports with
valves on a guide wire prevent advancement of coaxial systems, that
very often need to be changed. For instance, different balloon
diameters may be needed in the procedure. Sometimes, one balloon
may need to be replaced with a balloon of a different diameter.
Systems to deploy a stent and systems to expand a stent with a
balloon also may require coaxial systems. The presence of a port on
the guide wire would obligate the operator to deflate and remove
the guide wire every time he needed to exchange the coaxial system,
such as, for example, either to use a different balloon diameter
catheter or to advance a delivery system for stent deployment.
Therefore, there is needed in the art a device and method that
allows for the inflation and deflation, without the need of a port
on the guide wire, of a balloon carried on a guide wire. There is
needed a device and method which allow for the use of coaxial
systems to be placed over the guide wire to allow for the use and
placement of instrumentation needed during the medical procedure
without the necessity of deflating the balloon and removing the
guide wire.
The present invention recognizes that a balloon situated on a
hollow guide wire, where the hollow guide wire permits insertion of
a core segment into the lumen of the guide wire, will allow for
easy and convenient inflation and deflation of the balloon while
permitting coaxial systems to be introduced over the guide wire.
Thus, the present invention allows for the rapid exchange of
coaxial systems without the need to disconnect or connect ports
which in prior art have been attached to the guide wire.
SUMMARY OF THE INVENTION
The invention comprises a hollow guide wire with a plurality of
orifices extending from the exterior of the guide wire to its
lumen, an attached balloon which covers the orifices and a core
segment. The core segment may be inserted into the lumen of the
guide wire and then removed from the lumen of the guide wire when
the open end of the guide wire is inserted in a solution. The core
segment is sized to fit snugly within the lumen of the guide wire
and serves as a piston to inflate the guide wire balloon.
The guide wire is provided with a closed end and an open end which
form a tubular body having an internal lumen. Near the closed end
of the guide wire there is a guide wire balloon, which may be
expandable against the vascular duct to occlude the blood flow.
The guide wire with attached guide wire balloon have a low profile
allowing the insertion and advancement of coaxial balloon catheters
and stent delivery systems over the guide wire without disturbing
the inflated guide wire balloon.
In use, the operator takes the guide wire with the core segment
positioned inside the lumen of the guide wire and with the guide
wire balloon in its uninflated position on the guide wire, and
inserts the closed end of the guide wire with the attached guide
wire balloon into the patient through methods known in the art,
such as percutaneously into the femoral artery. Then, the guide
wire balloon is advanced through the vessel and positioned at the
appropriate location in the patient. The open end of the guide wire
is inserted inside a solution. A solution of normal saline mixed
with non-ionic contrast media may be used. In particular, a
solution consisting of 50% normal saline and 50% non-ionic contrast
media may be used. The core segment is removed from the lumen of
the guide wire with the open end of the guide wire inserted within
the solution. The solution fills the lumen of the guide wire. Then,
the core segment is gently advanced toward the guide wire balloon
until the guide wire balloon is fully dilated. The guide wire
balloon is thus expanded against the vascular walls. Once the guide
wire balloon is inflated, the core segment is fixed in position
within the guide wire by a locking mechanism which does not
increase the profile of the guide wire. Therefore, the advancement
of coaxial systems over the guide wire is allowed. Coaxial systems
may be exchanged without the need to deflate the guide wire
balloon.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view of the guide wire with the guide wire balloon in
its deflated position.
FIG. 2 is a view of the core segment which has not been inserted
into the lumen of the guide wire.
FIG. 3 is a longitudinal cross-section of the hollow guide wire
showing the orifices of the guide wire.
FIG. 4 is a view, partly in section, of the guide wire showing an
inflated guide wire balloon attached thereto.
FIG. 5 is a view of the open end of the guide wire showing an
embodiment of the guide wire with a groove and two spaces, which
are part of a locking mechanism.
FIG. 6 is a view of a portion of one embodiment of the invention,
showing the open end of the guide wire with the core segment
inserted into the lumen of the guide wire, with the knob of the
core segment engaging one of the housing spaces of the guide wire
to immobilize the core segment in its locked position.
FIG. 7 is a view of the distal end of one embodiment of the core
segment, showing three rings, which are a sealing mechanism.
FIG. 8 is a view of the operator end of one embodiment of the core
segment, showing the knob, which is a part of the locking
mechanism.
FIGS. 9 and 10 are views showing the apparatus of the present
invention with the balloon in the uninflated and inflated
configurations, respectively.
FIGS. 11 and 12 are longitudinal cross-sections of the portion of
guide wire containing the distal end of the core segment.
FIGS. 13 through 17 are views depicting an alternative method of
inflating the apparatus of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIGS. 1 to 4, the balloon inflation device (10) of the
present invention, for use in carotid angioplasty, comprises a
guide wire (14) having a guide wire balloon (20) near the closed
end (24) of the guide wire and a core segment (30) which may be
inserted into the lumen (34) of the guide wire. The guide wire
balloon (20) may be integral with the guide wire (14) and may be
formed on the guide wire by means known in the art. The core
segment (30) may be moved in an axial direction in the lumen of the
guide wire. In a preferred embodiment for use with carotid
stenting, the length of the guide wire is 2.3 meters and the length
of the core is 2.4 meters. However, other lengths of the guide wire
and core may be used.
The guide wire (14) comprises a cylinder body (16) having a closed
end (24) and an open end (36). The cylinder body (16) of the guide
wire (14) forms by its inner wall (15) in its interior a lumen (34)
of the guide wire. Preferably, the guide wire is made of metal. As
shown in FIG. 3, the guide wire (14) has a plurality of orifices
(18) near its closed end. In a preferred embodiment the guide wire
(14) has two or three such orifices (18). The orifices (18) are
openings which extend from the outside of the guide ire (14) into
the lumen (34) of the guide wire. Preferably, these orifices (18)
are made in different segments of different circumferences of the
guide wire. Preferably, these orifices are 1 or 2 mm apart, one
from each other. The area of the guide wire with the orifices (18)
is covered by the guide wire balloon (20), preferably made of
silicon or polyurethane.
Preferably, the core segment (30) is inserted into the guide wire
(14) before the guide wire balloon (20) is placed to cover the
orifices (18) of the guide wire (14). As shown in FIG. 2, a core
segment (30) comprises a solid body (31) and has an operator end
(52) and a distal end (50). The core segment (30) corresponds to
the lumen of the guide wire. The core segment (30) is inserted into
the lumen (34) of the guide wire, so that the distal end (50) of
the core segment (30) first enters the lumen (34) of the guide
wire. The core segment (30) provides rigidity to the guide wire
(14). The core segment (30) is slightly smaller in width than the
lumen (34) of the guide (14) so as to allow the advancement of the
core segment (30) within the lumen (34) of the guide wire (14), but
must be of sufficient width so as to not allow seepage of fluid
around the core segment (34), when the core segment (34) is
properly sealed within the lumen (34) of the guide wire 914) by a
sealing mechanism. Such sealing may be accomplished by a variety of
means.
The core segment (34) may be fitted with a plurality of rings (32),
which attach around the core segment, or the core segment may be
covered at its distal end portion with a layer of sealing material,
the rings (32) or the sealing material, being made of silicone or
other appropriate material, such as TEFLON.TM., to provide a
watertight seal of the core segment (34) with the inner wall (15)
of the guide wire to prevent leakage of fluid around the core
segment (30).
The core segment (30) is inserted within the guide wire (14) so as
to seal the guide wire (14) in the same way a piston adapts to a
cylinder. The core segment (30) is sized in dimension such that
there is no noticeable gap between the core segment (30) and the
guide wire (14). If the fitting of the core segment (30) within the
lumen (34) of the guide wire (14) is not watertight, solution would
leak, allowing the guide wire balloon (20) to deflate. Therefore,
the core segment (30) must be fitted within the lumen (34) of the
guide wire (14), and such fitting may employ the use of seals,
rings or the like, so as to be watertight to prevent leakage of
fluid around the core segment when the core segment (30) is within
the guide wire (14).
Rings, such as those made of TEFLON.TM., silicone or the like, may
be inserted into the lumen (34) of the guide wire (14) and placed
so as to seal the lumen (34) of the guide wire 914) against the
core segment (30), when the core segment (30) is within the guide
wire (14). Alternatively, as shown in FIG. 2, rings (32), such as
those made of TEFLON.TM., silicone or the like, may be placed at
the distal end (50) of the core segment (30), so that when the core
segment (30) is within the guide wire (14) there is a watertight
seal between the sides of the core segment and the inner wall (15)
of the guide wire (14).
Preferably, two or three rings either within the end of the guide
wire (14) or attached to the outside distal end (50) of the core
segment (30) may be used to accomplish this watertight seal.
Alternatively, the distal end (50) of the core segment (30) may be
covered with silicone or TEFLON.TM. to seal the core segment so
that no fluid may leak around the core segment (30) when the core
segment (30) is positioned within the lumen (34) of the guide wire
(14).
Thus, the guide wire (14) has a low profile, because the core
segment (30) used to inflate and deflate the guide wire balloon
(20) is inserted into the lumen (34) of the guide wire (14) and
therefore does not increase the profile of the guide wire. The
guide wire (14) avoids the use of a portion for inflation of the
guide wire balloon (20), as such port is described in the prior
art, which port would increase the profile of the guide wire.
Therefore, coaxial systems can be applied over the guide wire (14)
of this invention. Typically, balloon catheters and stent delivery
systems may be applied over the guide wire (14) without having to
deflate the guide wire balloon.
As shown in FIG. 8, the guide wire (14) and core segment (30) may
be fitted with a locking mechanism to achieve, when needed, an
immobilization of the core segment (30) in relation to the guide
wire (14). Such locking mechanism may be achieved without
significantly increasing the profile of the guide wire (14). In a
preferred embodiment of a locking mechanism, the core segment (30)
has a very small prominent knob (6), preferably made of metal or
other biocompatible material, which does not extend beyond the
outer diameter of the guide wire (14) and which is located near the
operator end (52) of the core segment (30). In this embodiment of
the locking mechanism, the guide wire (14) has a narrow groove (7),
preferably of 3 cm length, which extends longitudinally from the
open end (36) of the guide wire (14) toward the closed end (24) of
the guide wire (14).
Referring to FIG. 7, the groove (7) has a plurality of side housing
spaces (8), preferably 3 cm apart, one to each other. Preferably,
there are two or three side housing spaces (8). Preferably, each
side housing space (8) is perpendicular to the groove (7) in the
guide wire (14). The knob (6) fits within a selected side housing
space (8). The core segment (30) is immobilized at the chosen level
by rotating the core segment (30) until the knob (6) of the core
segment enters the side housing space (8) of the guide wire (14),
which thereby locks the core segment in its position within the
lumen (34) of the guide wire (14).
In use, after the core segment (30) has been inserted into the open
end of the guide wire and positioned, it may be locked and kept
immobilized to keep the balloon inflated, as illustrated in FIG. 6.
In particular, the knob (6) of the core segment (30) engages one of
the housing spaces (8) of the guide wire (14) when the core segment
(30) is in its locked position within the guide wire (14). The
mechanism of locking consists of moving the core segment inside the
guide wire (14) so as to position the knob (6) at the same point in
the circumferences as the groove (7) of the guide wire.
Once the knob (6) enters the groove (7), attention is paid to the
guide wire balloon (20) to determine that it is fully inflated. If
the balloon is fully inflated the core segment (30) should be
locked in position up to the end of the procedure to keep the
balloon fully inflated. The core is locked within the guide wire by
a gentle rotation of the core segment (30) to install the knob (6)
inside the side housing space (8).
After the medical procedure is carried out, the core segment (30)
is unlocked and the guide wire balloon (20) is deflated by
reversing the rotation of the core segment (30) to release the knob
(6) of the core segment from the housing space (8) of the guide
wire (14). Thus, the guide wire balloon (20) has a first
configuration of reduced size in its uninflated state (FIG. 9) and
a second configuration of expanded size in its inflated state (FIG.
10), the guide wire balloon (20) being expandable from its first
configuration to its second configuration.
In use the guide wire balloon (20) is in its uninflated
configuration when the guide wire (14) with guide wire balloon (20)
is introduced into the patient. At the appropriate time when the
operator chooses to expand the guide wire balloon (20) against the
vascular duct to occlude the blood flow the guide wire balloon may
b expanded according to the following actions. In carotid stenting,
the guide wire may be positioned at the desired location of
occlusion, such as in the internal carotid artery beyond the
stenosis, before the guide wire balloon (20) is inflated.
The open end (36) of the guide wire (14) is inserted inside the
desired solution, used to inflate the guide wire balloon, such as a
normal saline mixed with non-ionic contrast media. Preferably, a
solution consisting of 50% normal saline and 50% non-ionic contrast
media is used. The solution may be kept available inside a basin.
The core segment (30) is removed from the lumen (34) of the guide
wire (14) with the open end of the guide wire (14) inserted within
the saline/contrast media solution. When the core segment (30) is
removed it creates a vacuum inside the lumen (34) of the guide wire
(14) which is then immediately filled by the solution. The
saline/contrast media solution fills the lumen (34) of the guide
wire (14).
As illustrated in FIG. 10, the core segment (30 then is gently
advanced toward the guide wire balloon (20) until the guide wire
balloon (20) is fully dilated. The solution flows through the
orifices (18) of the guide wire (14) into the guide wire balloon
(20) to inflate the guide wire balloon (20). As further depicted in
FIG. 11, the distal end of the core first is advanced inside the
hollow guidewire (14) so that the rings (32) follow the direction
of the core. Once the final position has been reached, the rings
are reversed by gently pulling the core out, thereby sealing the
guidewire cavity. The guide wire balloon (20) is thus expanded
against the vascular walls. The core segment (30) may be locked in
the guide wire (14) and kept in position to maintain the inflation
of the guide wire balloon (20) during the time needed for the
procedure.
After expansion of the guide wire balloon (20), endovascular
procedures, such as carotid stenting, may be performed. For
example, a catheter, balloon of angioplasty, a stent or any other
suitable apparatus or instrument may be passed by way of a coaxial
system over the guide wire (14) to reach the appropriate area of
the vascular walls for appropriate treatment.
Once the procedure is finished and when the expanded guide wire
balloon (20) is no longer needed in its expanded position, the core
segment (30) is unlocked and withdrawn from the lumen (34) of the
guide wire (14) until the guide wire balloon (20) is completely
deflated. Thus, the guide wire balloon may be returned to its
uninflated position by removing the core segment (30) from the open
end (36) of the guide wire (14).
In particular, a new method for inflating and deflating a guide
wire balloon (20) is described below, wherein the operator uses a
balloon inflation device (10) in which a core segment (30) has been
inserted into the open end (36) of the guide wire (14) and
positioned at the closed end (24) of the guide wire (14), and the
orifices (18) on the guide wire (14) are covered by a guide wire
balloon (20).
The operator inserts the closed end (24) of the guide wire (14)
into the patient, by means known in the art, such as percutaneously
into the femoral artery and then positions the guide wire balloon
at the appropriate location of intended use in the body. The core
segment (30) may be removed from the guide wire (14) when the open
end (36) of the guide wire (14) is inside a basin full of solution,
such as normal saline mixed with non-ionic contrast media. When the
core segment (30) is removed from the lumen (34) of the guide wire
(14), it creates a vacuum inside the lumen (34) of the guide wire
which is filled immediately with the solution. Then, the core
segment (30) is gently advanced toward the guide wire balloon (20)
until the guide wire balloon (20) is fully distended. Through a
locking mechanism the core segment (30) is kept in position during
the time needed for the procedure. Coaxial systems, such as balloon
catheter and stent delivery systems, may be applied over the guide
wire (14) without deflating the guide wire balloon (20). After the
procedure, which may generate emboli, is completed, the core
segment (30) is unlocked and retrieved and the guide wire balloon
(20) is thereby deflated.
In alternative embodiments of the invention, the methods and
apparatus can be used in other procedures and repairs of the
anatomy, where there is a need to inflate an occlusion balloon to
protect against dangerous emboli. In such procedures, the
convenient method and apparatus for the inflation and deflation of
a balloon may be likewise useful.
Referring to FIGS. 13 to 17, one such alternative embodiment is
described. As shown in FIGS. 13 and 14, inflation device (60)
comprising syringe (61) coupled to flexible and collapsible shaft
(62) is advanced over guidewire (14). Syringe (61) serves for air
removal and balloon inflation with a diluted contrast solution.
Once the balloon (20) is inflated by operating syringe (61), a
clamp (70) is applied to the soft segment of the shaft (62),
thereby keeping the fluid inside of guidewire (14) and balloon
(20).
As shown in FIG. 16, core segment (30) is advanced through an
opening in the back of syringe (61) and inside the lumen of the
shaft (62). Core segment (30) is sized to tightly seal the lumen of
shaft (62) to prevent leaking of the contrast solution. Once the
core segment (30) reaches the clamp (70), the clamp (70) is
removed, and the core segment is advanced inside the lumen of
guidewire (14), as described hereinabove. Core segment (30) is then
locked in place in slot (7) of the guide wire (14). As depicted in
FIG. 17, shaft (62) and syringe (61) then are removed, thereby
providing a small profile over which interventional instruments may
be coaxially advanced.
Having described this invention with respect to its preferred
embodiments, it is to be understood that the description is not
meant as a limitation since further variations or modifications may
be apparent or may suggest themselves to those skilled in the art.
It is intended that the present application cover such variations
and modifications as fall within the scope of the appended
claims.
* * * * *